Efficacy and Safety of BI 1356 in Combination With Metformin in Patients With Type 2 Diabetes

This study has been completed.

Sponsor:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT00622284

First Posted: February 25, 2008

Last Update Posted: January 29, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

There were in total 1560 patients randomised in the study. Of these, 1 patient was not treated. The remaining 8 patients not accounted for in the treated set were removed from all study analyses (explained in trial report) due to major good-clinical-practice violations at the site, and the inability to verify the validity of any patient level data.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

No text entered.

Reporting Groups

Description

Linagliptin

Patients randomized to receive Linagliptin 5mg and metformin

Glimepiride

Patients randomized to receive Glimepiride 1-4mg and metformin

Participant Flow: Overall Study

Linagliptin

Glimepiride

STARTED

776 [1]

775 [2]

COMPLETED

587 [3]

604 [3]

NOT COMPLETED

189

171

Lack of Efficacy

45

15

Adverse Event

61

90

Protocol Violation

12

5

Lost to Follow-up

11

13

Withdrawal by Subject

27

24

Other reason (not specified)

33

24

[1]

Number who started treatment. One patient in the Linagliptin group was randomized but not treated.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

The percentage of patients with an HbA1c value below 6.5% at week 52, based upon patients with baseline HbA1c >= 6.5%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c >= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.

Time Frame

Week 52

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c >=6.5%.

Reporting Groups

Description

Linagliptin

Patients randomized to receive Linagliptin 5mg and metformin

Glimepiride

Patients randomized to receive Glimepiride 1-4mg and metformin

Measured Values

Linagliptin

Glimepiride

Participants Analyzed [Units: Participants]

738

740

Percentage of Patients With HbA1c <6.5% at Week 52 [Units: Percentage of patients]

16.9

22.7

Statistical Analysis 1 for Percentage of Patients With HbA1c <6.5% at Week 52

Groups [1]

All groups

Statistical Test Type [2]

Superiority or Other

Statistical Method [3]

Regression, Logistic

P Value [4]

0.0025

Odds Ratio (OR) [5]

0.648

95% Confidence Interval

0.489 to 0.859

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

Linagliptin versus Glimepiride

[2]

Details of power calculation, definition of non-inferiority margin, and other key parameters:

No text entered.

[3]

Other relevant method information, such as adjustments or degrees of freedom:

The odds ratio is treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.

[4]

Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:

Limitations of the study, such as early termination leading to small numbers of participants
analyzed and technical problems with measurement leading to unreliable or uninterpretable data

With the exception of HbA1c<6.5% and HbA1c<7.0% at Week52, all other endpoints are presented in the Week52 repeated analysis within the final clinical trial report, where discrepancies between interim and final results are also explained.